Viewing the right 483 is helpful, analyzing 100K+ enforcement documents is powerful
Dive into the largest database of FDA 483s and global enforcement documents.
This demo will teach you how to:
- Search over 25K 483s to find the one you need
- Examine Investigator Profiles for inspection prep
- Analyze inspection outcomes mapped to quality system
- View 300,000+ Site and Organization profiles with full inspection history
Integrated data, intelligence,
visualizations, and workflows
Proprietary data sourcing powered by the Freedom of Information Act (FOIA)
and web crawling from >15,000 individual data sources
- >200 Agencies and Standards bodies
- Industry coverage includes: Human Drugs, Biologics, Medical Devices & IVD, Combination Products, Animal Health, and Food
- GxP coverage includes: GLP, GMP, GCP, GMP for IMP, GVP, and GDP
- >4,500 Inspector Profiles
- >300,000 Site and Organization Profiles
- >100k regulatory documents – 483s, Warning Letters, Untitled Letters, Certificates of Non-Conformance, Regulations, Guidance, etc
We seamlessly integrate data science capabilities with expert intelligence- including AI, natural language processing, machine learning, into the data pipeline to extract additional value.
Bringing everything together
Our team assimilates, normalizes, and categorizes large amounts of unstructured data to make sure all entities are represented and connected. The RedicaID provides a real-time view into evolving data by tracking inspections, enforcement actions, regulatory publications, and M&A activity. In a complex landscape that’s always in flux, the RedicaID is a reliable constant.
“Redica is an essential tool for our quality unit. I know our team will be fully prepared if an investigator arrives at our facility tomorrow. No guesswork here. With a simple search I can have enforcement trends by specific keywords presented quickly and clearly.”
“This is truly remarkable. I have never seen analytics this granular for GCP.”
“We didn’t know what we didn’t know. Now, Redica helps us be more risk-based and to refine our agenda for audits.”